A study to investigate the pharmacodynamic effect after four-week omeprazole treatment of non-erosive reflux disease in a Japanese population

Study identifier:D9587C00002

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A double-blind, randomised, parallel-group, multicentre, Phase III study to investigate the pharmacodynamic effect by assessment of the 24 hours intraesophageal pH level, the efficacy and safety of omeprazole 10mg and 20mg od in patients with non-erosive reflux disease (NERD).

Medical condition

Non-erosive reflux disease

Phase

Phase 3

Healthy volunteers

No

Study drug

Omeprazole

Sex

All

Actual Enrollment

40

Study type

Interventional

Age

20 Years +

Date

Study Start Date: 01 Jan 2004
Primary Completion Date: 01 Aug 2004
Study Completion Date: 01 Aug 2004

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2011 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

Mitsubishi Pharma Corporation

Inclusion and exclusion criteria